Bausch + Lomb Announces Statistically Significant Topline Results from Second Phase 3 Trial of NOV03

Bausch + Lomb and Novaliq announced statistically significant topline data from the second Phase 3 (MOJAVE) trial evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The companies announced statistically significant topline data from the first Phase 3 trial (GOBI trial) in April 2021.

“The findings from this second Phase 3 trial reinforce the results of the first Phase 3 trial and further supports the efficacy and safety profile of NOV03 as a potential important new treatment option for the millions of people living with dry eye disease associated with MGD,” said Joseph C. Papa, chairman and CEO, Bausch Health. “These results mark another important milestone in bringing NOV03 to market as a potential first-in-class treatment, and we anticipate filing a New Drug Application to the U.S. Food and Drug Administration in 2022.”

The MOJAVE trial met both primary sign and symptom endpoints, and also met all of its secondary endpoints, showing statistically significant improvements in each of the signs and symptoms of DED associated with MGD that were evaluated.

“We are extremely pleased by the consistency of the results, which reaffirm the safety and efficacy results for this investigational drug previously demonstrated in a Phase 2 trial and the first Phase 3 trial. This underscores the potential impact NOV03 could have, if approved, in addressing an unmet medical need for the millions of patients with dry eye disease associated with MGD,” said Christian Roesky, Ph.D., CEO, Novaliq.

The clinical development program for NOV03 is expected to conclude with an ongoing multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).

Click HERE for the full press release.

Related:

Bausch + Lomb Announces Results from First Phase 3 Trial of NOV03

Featured Posts

Memory of Maria Luisa Pramaor: Founder, Guiding Light, and Heart of Blackfin

On Friday, September 22, Blackfin heartbreakingly and suddenly bereaved of Maria Luisa Pramaor.

Learn More

Ray-Ban and Meta Launch Next Generation of Smart Glasses

The new Ray-Ban I Meta smart glasses features Meta AI, advanced audio and camera capabilities, design customization opportunities, and expanded European distribution

Read more

MIDO Opens CSE Award application and Visitor Registration

MIDO exhibitors can apply to participate in the Certified Sustainable Eyewear (CSE) Award, and registration is now open.

Read more

PPG, Flō-Optics Announce Exclusive Supplier Agreement for First Digitally Applied Optical Coatings

3D printing featuring PPG HI-GARD lens coatings provides durability, scratch resistance

Read more

Creating a Positive Contact Lens Culture Requires Multifactorial Approach, Says New Research Previewed at VEW

Contact Lens Institute™ & The Vision Council Offer Sneak Peek at Forthcoming Report

Read more

Memory of Maria Luisa Pramaor: Founder, Guiding Light, and Heart of Blackfin

On Friday, September 22, Blackfin heartbreakingly and suddenly bereaved of Maria Luisa Pramaor.

Learn More

Ray-Ban and Meta Launch Next Generation of Smart Glasses

The new Ray-Ban I Meta smart glasses features Meta AI, advanced audio and camera capabilities, design customization opportunities, and expanded European distribution

Read More

MIDO Opens CSE Award application and Visitor Registration

MIDO exhibitors can apply to participate in the Certified Sustainable Eyewear (CSE) Award, and registration is now open.

Read More

PPG, Flō-Optics Announce Exclusive Supplier Agreement for First Digitally Applied Optical Coatings

3D printing featuring PPG HI-GARD lens coatings provides durability, scratch resistance

Read More

Creating a Positive Contact Lens Culture Requires Multifactorial Approach, Says New Research Previewed at VEW

Contact Lens Institute™ & The Vision Council Offer Sneak Peek at Forthcoming Report

Read More

Memory of Maria Luisa Pramaor: Founder, Guiding Light, and Heart of Blackfin

On Friday, September 22, Blackfin heartbreakingly and suddenly bereaved of Maria Luisa Pramaor.

Learn More

Ray-Ban and Meta Launch Next Generation of Smart Glasses

The new Ray-Ban I Meta smart glasses features Meta AI, advanced audio and camera capabilities, design customization opportunities, and expanded European distribution

Read more

MIDO Opens CSE Award application and Visitor Registration

MIDO exhibitors can apply to participate in the Certified Sustainable Eyewear (CSE) Award, and registration is now open.

Read more

PPG, Flō-Optics Announce Exclusive Supplier Agreement for First Digitally Applied Optical Coatings

3D printing featuring PPG HI-GARD lens coatings provides durability, scratch resistance

Read more

Creating a Positive Contact Lens Culture Requires Multifactorial Approach, Says New Research Previewed at VEW

Contact Lens Institute™ & The Vision Council Offer Sneak Peek at Forthcoming Report

Read more

Memory of Maria Luisa Pramaor: Founder, Guiding Light, and Heart of Blackfin

On Friday, September 22, Blackfin heartbreakingly and suddenly bereaved of Maria Luisa Pramaor.

Learn More

Ray-Ban and Meta Launch Next Generation of Smart Glasses

The new Ray-Ban I Meta smart glasses features Meta AI, advanced audio and camera capabilities, design customization opportunities, and expanded European distribution

Read more

MIDO Opens CSE Award application and Visitor Registration

MIDO exhibitors can apply to participate in the Certified Sustainable Eyewear (CSE) Award, and registration is now open.

Read more

PPG, Flō-Optics Announce Exclusive Supplier Agreement for First Digitally Applied Optical Coatings

3D printing featuring PPG HI-GARD lens coatings provides durability, scratch resistance

Read more

Creating a Positive Contact Lens Culture Requires Multifactorial Approach, Says New Research Previewed at VEW

Contact Lens Institute™ & The Vision Council Offer Sneak Peek at Forthcoming Report

Read more